Kornimate/medical-research-clean huggingface dataset:
bioequivalency study of zaleplon 10 mg capsules under fed conditions

Conditions: Short Term Treatment of Insomnia

Summary: the objective of this study was the bioequivalence of a roxane laboratories' zaleplon capsules, 10 mg, to sonata ® capsules, 10 mg (jones pharma) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to zaleplon or any comparable or similar product.
quality control project of stroke in liaoning province

Conditions: Stroke, Ischemic

Summary: to reduce the incidence of stroke and standard the treatment of stroke in liaoning province, the present study should be conducted.


Eligibility criteria:
inclusion criteria: * ischemic stroke exclusion criteria: * disagreed patients

Keywords: prevention
the effect of prophylactic hemodialysis on the morbidity and mortality of the patients with chronic kidney disease stages 3-4 undergoing coronary artery graft bypass

Conditions: Chronic Kidney Disease stage3; Chronic Kidney Disease stage4; Coronary Artery Disease

Summary: coronary artery disease is a major cause of death in patients with renal dysfunction among patients who undergo coronary artery bypass grafting ,renal dysfunction is known to be a major predictor of in-hospital and remote mortality as little is known about the impact of non-dialysis-dependent renal dysfunction on short and mid term outcomes following coronary surgery we have decided to investigate the effect of prophylactic hemodialysis on the mortality and morbidity of the patients with ckd (stage 3,4 ) and compare these effect with the control group


Eligibility criteria:
inclusion criteria: * 80\ 18 * ckd patients with stage 3,4 * cabg for the first time exclusion criteria: * age\<18 * previous cabg (coronary artery bypass grafting) * aki(acute kidney injury) * dialysis patients
inspiratory resistive loading and diaphragm fatigue

Conditions: Diaphragm Fatigue; Healthy; Low Back Pain

Summary: the aim of the study is to clarify whether specific loading of the inspiratory muscles induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals with recurrent low back pain.


Eligibility criteria:
inclusion criteria individuals with low back pain: * age: 18-35 years old * at least 1 year of low back pain with/without referred pain in buttock/thigh * at least 3 episodes of disabling low back pain * at least a score of 20% on the oswestry disability index * willingness to sign the informed consent inclusion criteria healthy individuals: * age: 18-35 years old * no history of low back pain * a score of 0% on the oswestry disability index * willingness to sign the informed consent exclusion criteria: * history of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant * one of the following conditions: parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy * radicular symptoms * not dutch-speaking * strong opioids * neck pain * smoking history
changes in quality of recovery with low-flow anesthesia (qorinlowflow)

Conditions: Low Flow Anesthesia

Summary: postoperative recovery quality is as important as patient satisfaction and clinical results in terms of a fast and high-quality surgical process. this study was conducted to investigate the effect of low-flow anesthesia applications on the quality of patient recovery by evaluating the 'quality of recovery' (qor40) test and the perception tests (pqrs cognitive test) performed in the early postoperative period.

all patients will be evaluated preoperatively in the anesthesia outpatient clinic, their consent will be obtained, and they will be informed about the 'postoperative recovery evaluation' and pre-tests will be performed. all patients will receive premedication midazolam 0.07mg/kg intramuscularly 20 minutes before the operation. in both groups, anesthesia induction will be achieved with intravenous propofol 3 mg/kg, remifentanil 0.1 mic/kg, and rocuronium 0.06 mg/kg. following endotracheal intubation, maintenance of anesthesia will be provided to the patients in group i by inhalation, with sevoflurane mac 1 in o2/air 1/3 (4lt/min). on the other hand, patients in group ii will be switched to o2/air 0.16/0.48 (0.5 lt/min) low flow anesthesia 15 minutes after the depth of anesthesia is provided (bis\ 70. the extubation time will be recorded. postoperative recovery evaluations of the patients will be made. nausea/vomiting and modified aldrete scores and vas values of the patients followed for 30 minutes in the recovery unit will be recorded. at the end of the first 30 minutes, pqrs cognitive test will be applied to the patients. on the morning of the first postoperative day, the qor40 test will be applied and scored by an anesthesia technician who does not know the anesthesia method. the results will be compared.

Eligibility criteria:
inclusion criteria: 1. cases in which general anesthesia will be applied by intubation and anesthesia will be maintained with inhalation anesthetics; 2. 2 - 6 hour cases 3. 18 - 60 years old 4. low flow anesthesia application with 0.5 lt/min flow rate 5. patients undergoing muscular recovery with sugammadex exclusion criteria: 1. patients with bleeding diathesis or patients with bleeding in excess of 400 ml 2. patients with mental/neurological problems 3. patients who refused to participate in the study and could not respond 4. patients who cannot apply low current 5. uncooperative patients with delirium 6. hypotension in perioperative parameters (map \< 40 mmhg) 7. patients with diabetic ketoacidosis 8. cases taken when soda lime is dry

Keywords: low flow anesthesia quality of recovery cognition tests postoperative complications
eosinophilic esophagitis steroid safety study

Conditions: Eosinophilic Esophagitis

Summary: this observational study will follow pediatric patients with eosinophilic esophagitis who are scheduled to begin topical steroid treatment, from the initiation of treatment longitudinally to determine the safety profile of the drug.


Eligibility criteria:
inclusion criteria: 1. age \<18 years at the time of enrollment. 2. males and females are included. 3. patients diagnosed with eoe as defined by age appropriate signs of esophageal dysfunction (in older children and adolescents - dysphagia, impacted food bolus, foreign body impaction, vomiting, and gerd not responsive to high dose proton pump inhibitors. in infants and young children - failure to thrive, poor feeding, vomiting, food bolus impaction) 4. histopathological finding of ≥15 eosinophils/high power field (x400) on at least one esophageal biopsy. 5. after discussing the available treatment options with the gastroenterologist, the patient has chosen oral topical steroid treatment (either as a first treatment or after failure of other dietary or medical treatment). exclusion criteria: 1. known alternative causes of esophageal eosinophilia. 2. legal guardian unable or unwilling to sign informed consent.. 3. known allergy to topical steroids ingredients 4. patient will not be available for follow-up for at least the 3 month assessment and acth test. 5. known pregnancy 6. use of oral systemic steroids in the 6 months prior to inclusion in the study. use of systemic steroids once in the study will not lead to study termination, but such use will need to be reported in the medication changes and use page of the following visit.

Keywords: steroid , bone mineral density , dexa , adrenal
role of pet/ct in peritoneal deposits assessment

Conditions: Peritoneal Metastases

Summary: • suspected patients known to have a primary malignant tumour, patients with metastasis of unknown primary and had incidental peritoneal lesions and will do pet/ct for assessment of peritoneal deposits

suspected patients known to have a primary malignant tumour, patients with metastasis of unknown primary and had incidental peritoneal lesions and will do pet/ct for assessment of peritoneal deposits. we will find its diagnostic role.

Eligibility criteria:
inclusion criteria: * • suspected patients known to have a primary malignant tumour, patients with metastasis of unknown primary and had incidental peritoneal lesions. exclusion criteria: * • patients unable to sit calm without movement during imaging. * severely ill patients. * patients unable to sleep in a fixed position for 20 minutes. * pregnancy
a study of bbi608 in combination with pemetrexed and cisplatin in adult patients with malignant pleural mesothelioma

Conditions: Malignant Pleural Mesothelioma; Non-Small Cell Lung Cancer

Summary: this is an open-label, multicenter, phase 1/2 study of bbi608 in combination with pemetrexed and cisplatin chemotherapy as a 1st line treatment for malignant pleural mesothelioma (mpm).


Eligibility criteria:
phase 1 inclusion criteria: * histologically confirmed diagnosis of malignant pleural mesothelioma (mpm) or non-small cell lung cancer (nsclc). * measurable disease as defined by the modified response evaluation criteria in solid tumors (mrecist) for mpm or the recist 1.1 for nsclc. * ≥ 20 years of age. * provision of written informed consent. * for male or female patient of child producing potential: must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * hemoglobin (hb) ≥ 9.0 g/dl. * neutrophils ≥ 1500/μl. * platelets ≥ 100,000/μl. * aspartate transaminase (ast) and alanine transaminase (alt) ≤ 2.5-fold the upper limit of normal range (uln) \[≤ 5-fold uln with any liver metastasis\]. * total bilirubin ≤ 1.5-fold uln. * creatinine clearance (estimated value) ≥ 60 ml/min. * life expectancy ≥ 3 months. * females of childbearing potential have a negative urine pregnancy test. phase 2 inclusion criteria: * histologically confirmed diagnosis of mpm. * treatment naïve and not indicated for resection. * measurable disease as defined by the modified recist. * ≥ 20 years of age. * provision of written informed consent. * for male or female patient of child producing potential: must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose. * ecog performance status of 0 or 1. * hb ≥ 9.0 g/dl. * neutrophils ≥ 1500/μl. * platelets ≥ 100,000/μl. * ast and alt ≤ 2.5-fold uln \[≤ 5-fold uln for patients with any liver metastasis\]. * total bilirubin ≤ 1.5-fold uln. * creatinine clearance (estimated value) \> 60 ml/min. * life expectancy ≥ 3 months. * females of childbearing potential have a negative urine pregnancy test. both phase 1 and 2 exclusion criteria: * prior anti-cancer chemotherapy and radiotherapy. * prior hormonal therapy, immunotherapy, thermotherapy, operation. * any brain metastasis requiring treatment or symptomatic. * active multiple primary cancers. * crohn's disease, ulcerative colitis, small intestine resection. * abnormal ecgs. * prior myocardial infarction. * current use of antiarrhythmic medication. * uncontrolled concurrent diseases. * known severe hypersensitivity to pemetrexed, cisplatin or other drugs containing platinum. * women who are pregnant or breastfeeding. * received other investigational drugs. * unable or unwilling to swallow bbi608 capsules daily. * prior treatment with bbi608. * ineligible for participation in the study in the opinion of the investigators.
immuno nutrition by l-citrulline for critically ill patients

Conditions: Intubation; Pulmonary Ventilation

Summary: the main objective of this study is to demonstrate that the only administration of l-citrulline, can improve immune functions in critically ill patients at high risk of nosocomial infection.

this is a multicentric therapeutic trial, randomized and double blind: standard enteral nutrition plus l-citrulline (5 grams/12 hours for 5 days from the admission in intensive care unit (icu)) versus standard enteral nutrition plus placebo. methods-patients: non-surgical patients admitted in medical intensive care unit, under mechanical ventilation for an expected duration \> 2 days, without severe sepsis or septic shock, will be enrolled. symptoms leading for icu admission ongoing for five days maximum. on admission (before treatment), the severity will be evaluated with the sepsis-related organ failure assessment (sofa) score together with an assessment of plasmatic arginine, cytokines (interleukin-6 (il6) ), and expression of human leukocyte antigen - antigen d related (hla-dr) by monocytes. the same evaluation will be repeated on day 3 (during treatment) and on day 7 (after treatment). the enrolment of 100 patients is statistically enough to demonstrate a decreased sofa scores in the l-citrulline group as compared to the placebo group on day 7.

Eligibility criteria:
inclusion criteria: * age \> 18 years * medical patient (absence of recent surgery or trauma) * initial aggression \< 5 days * mechanically ventilated with expected duration of mechanical ventilation \> 2 days * exclusive enteral nutrition * absence of previous immunosuppression exclusion criteria: * severe sepsis * septic shock * obesity defined as bmi above 40 * pregnancy
alzheimer's family caregiver intervention in vietnam

Conditions: Dementia Alzheimers

Summary: this is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a alzheimer's family caregiver intervention in vietnam.

this is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a modified version of the reach-va caregiver intervention in vietnam. the reach-va caregiver intervention is an evidence-based intervention that has been shown to be effective in multicultural populations in the us. the model has been modified for use in vietnam. this study will test the modified model in vietnam. participants in this study will be adult family caregivers of non-institutionalized persons with dementia who are living in hanoi, vietnam. they will receive 4-6 sessions delivered over the course of 2-3 months that will included the following components: 1) education about the nature of the disease, 2) risk assessment, 3) enhancing caregiver skills and problem-solving, and 4) caregiver stress reduction. the intervention will be delivered by a social worker or nurse using a vietnamese language versions of the reach-va protocol and caregiver intervention notebook.

Eligibility criteria:
inclusion criteria: * primary adult family caregiver of person with dementia exclusion criteria: * caregivers of persons with dementia who are institutionalized

Keywords: family caregiver
evaluation of discomfort associated with scleral depression during retina examinations

Conditions: Retina--Diseases; Retinal Detachment; Retinal Degeneration

Summary: scleral depression is an important technique used to examine the peripheral retina but often causes patient discomfort. the goal of this study was to compare levels of discomfort during scleral depression with a schocket scleral depressor and cotton tipped applicator.


Eligibility criteria:
inclusion criteria: * adult patients who received dilated eye examinations in the retina or general eye clinic exclusion criteria: * younger than 18 * pregnant * prior scleral buckle, filtering bleb or underwent any other ocular surgery within the past month

Keywords: scleral depression visual analog scale pain discomfort schocket scleral depressor cotton tipped applicator diabetes
esp block vs fib in patients undergoing hip arthroplasty

Conditions: Hip Arthropathy

Summary: the aim of this study is to compare between the analgesic efficacy of esp block and fib in patients undergoing hip arthroplasty.

hip arthroplasty surgery is usually associated with severe postoperative pain. several modalities are usually used for postoperative analgesia in these patients, those include; intravenous analgesia, neuraxial analgesia and peripheral nerve blocks. peripheral nerve blocks have several advantages such as; potent analgesia, lower motor impairment and minimal systemic complications. lumbar plexus block and supra-inguinal fascia iliaca block (fib) are the most commonly performed peripheral nerve blocks for hip surgeries. fascia iliaca block is one of the most common techniques for pain control after hip surgeries; it can be regarded as an anterior approach of the lumbar plexus. it provides analgesia through spread of local anaesthetic to the femoral and lateral cutaneous femoral nerves. ultrasound guided erector spinae plane (esp) block is a recent regional anesthetic technique. it was first described in 2016 for acute and chronic thoracic pain management. it is a paraspinal fascial plane block that provides analgesia through injecting local anesthetic drugs to block the ventral and dorsal rami of spinal nerves in the paravertebral area. to the best of the investigators knowledge, the use of esp block in hip surgery was only investigated in one study and few case reports. therefore, further randomized controlled studies are needed to prove this hypothesis. this study aims to investigate the efficacy of esp block in hip replacement compared to the supra-inguinal fib. the investigators hypothesize that erector spinae block may provide better postoperative analgesia than fascia iliaca block, since erector spinae block provides analgesic cover for the entire lumbar plexus rather than just peripheral nerves provided by fasicia iliaca.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * asa grade i to ii * patients scheduled for hip replacement surgeries under subarachnoid block (sab) e.g. hip hemi-arthroplasty, total hip arthroplasty exclusion criteria: * patient refusal * age below 18 or above 65 years. * asa grade iii to iv * patients with known allergies to any of the drugs used. * contraindication to sab eg. coagulopathy, infection at the injection site, severe cardiopulmonary disease, diabetic or other neuropathies. * patients receiving opioids for chronic analgesic therapy * inability to comprehend visual analogue scale (vas) * infection at site of erector spinae or fascia iliaca block. * body mass index \>35 kg/m2

Keywords: erector spinae block fascia iliaca block
post-license safety evaluation of influenza virus vaccine

Conditions: Influenza; Adverse Drug Event

Summary: to evaluate the safety of the post-licensed influenza virus vaccine made of changchun institute of biological products co.,ltd.

in order to evaluate the safety of the post-licensed influenza vaccine (the vaccine is manufactured by changchun institute of biological products co.,ltd in china), retrospectively collect the aefi cases reported from national aefi surveillance system in sichuan province of china in 2013, compare the incidence and proportion of local and general reactions, with other influenza vaccine. adverse events were collected through the national immunization information system's national adverse events following immunization (aefi) surveillance system, which was established in 2005 on the basis of world health organization (who) guidelines. according to the guideline for the identification of adverse reaction after immunization issued by the chinese ministry of health in 2008, sichuan cdc and local prefectural cdc must organize an expert panel to investigate adverse events and assess causality, using criteria based on chinese standard procedures for vaccination. at the time of vaccination, vaccinees were instructed to report any adverse event to physicians or vaccination providers. adverse events that were fatal or that resulted in disability and clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine) were required to be reported within 2 hours after their occurrence. the following adverse events were required to be reported within 2 days after their occurrence: anaphylaxis or other allergic reactions occurring within 24 hours after vaccination; fever (axillary temperature, \>37.5°c), angioedema, or a local injection-site reaction (diameter, \>2.5 cm) occurring within 5 days after vaccination; purpura, an arthus reaction, febrile convulsion, seizure, or polyneuritis occurring within 15 days after vaccination; and the guillain-barré syndrome occurring within 3 months after vaccination. other reactions that were common and minor (e.g., mild pain and fatigue) were not required to be reported.

Eligibility criteria:
inclusion criteria: * ever vaccinated one dose influenza vaccine(manufactured by changchun institute of biological product) in 2013 * above 3 years old exclusion criteria: * severe allergic reaction (e.g., anaphylaxis) after previous dose of any iiv or laiv * allergic to a vaccine component, including egg protein.

Keywords: aefi influenza vaccine
opioid-free orthopaedics

Conditions: Pain; Pain, Postoperative

Summary: the goal of this investigation is to compare effectiveness of this multimodal regimen at controlling postoperative pain with and without the use of opioid medications.

prolonged opioid usage after orthopaedic surgery is an important consideration for both the opioid epidemic and postoperative outcomes. the investigators have developed a multimodal pain control regimen designed to decrease or even potentially eliminate the need for opioids after an orthopedic procedure. this is a prospective double blinded randomized controlled trial utilizing a multimodal pain regimen consisting of education and our standard multimodal pain control regimen. then, the plan is to randomize patients to receive either encapsulated opioids or placebo. the team will assess patient's pain levels, satisfaction, opioid usage, side effects, patient reported outcomes, and complications. this study will serve as a foundation for future opioid-free surgeries and investigations, while helping to identify patients and factors at risk for prolonged opioid usage postoperatively.

Eligibility criteria:
inclusion criteria: * any patient with advanced arthritis undergoing a total joint replacement (e.g. total shoulder arthroplasty, anatomic or reverse), in the primary setting. * any patient undergoing an orthopaedic procedure or surgery of their finger, hand, wrist, forearm, or elbow * any patient undergoing an orthopaedic procedure or surgery for their hip, knee, ankle or foot * patients who have exhausted 3+ months of nonoperative treatment to include activity modifications, optional corticosteroid injections, and physical therapy. * patients over the age of 18 years old that are willing to participate in the study and mentally capable to consent exclusion criteria: * patients with concurrent and significant injuries to other bones or organs, local infections, history of alcohol or medical abuse, preoperative opioid use within 3 months of the surgery, advanced renal or liver disease, contraindication to receiving a nerve block, uncontrolled diabetes mellitus (hba1c \>9.0), or if a prior gastric ulcer precludes aspirin and anti-inflammatory medications.i. prior to inclusion, the patient will undergo blood testing to evaluate both kidney and liver function, including estimated glomerular filtration rate (gfr) as well as alanine aminotransferase (alt) and aspartate aminotransferase (ast). * workman's compensation status, minors, vulnerable subjects, women who are pregnant, or those who are not willing to consent to participate in the study. * patients who, in the opinion of the investigator, may be non-compliant with study schedules or procedures

Keywords: pain management oxycodone